Description

Drospirenone CAS NO 67392-87-4 is a synthetic steroidal progestin and a key active pharmaceutical ingredient (API). It is a critical component in modern hormonal contraceptive and hormone replacement therapies, valued for its anti-mineralocorticoid and anti-androgenic properties. This high-purity compound is essential for pharmaceutical manufacturers and research institutions developing innovative women's healthcare solutions.

Application

• Pharmaceutical API: Primary active ingredient in combined oral contraceptive pills (e.g., in combination with ethinyl estradiol).
• Hormone Replacement Therapy (HRT): Used in formulations to manage menopausal symptoms.
• Treatment of Premenstrual Dysphoric Disorder (PMDD): Incorporated into therapeutic regimens for severe premenstrual syndrome.
• Acne Treatment: Utilized in certain hormonal therapies for its anti-androgenic effects.
• Pharmaceutical R&D: Serves as a reference standard and starting material for novel drug development and metabolic studies.
• Generic Drug Manufacturing: Critical for producing bioequivalent versions of branded hormonal medications.

Basic Information

Product Name	Drospirenone
CAS No.	67392-87-4
Molecular Formula	C24H30O3
Molecular Weight	366.50 g/mol
Synonyms	6β,7β;15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone; 1,2-Dihydrospirorenone; 6β,7β-15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone; ZK 30595; SH 440; Yasmin (brand name component); Angeliq (brand name component); DRSP
EINECS	Contact for details

Quality Control

Our Drospirenone is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical applications. Quality is assured through comprehensive analytical testing, including HPLC for purity and identity confirmation. A Certificate of Analysis (COA) is provided with each batch, detailing compliance with agreed specifications. We support compliance with major pharmacopoeial standards (e.g., USP, EP) and relevant ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on dried basis)
Loss on Drying	≤ 0.5%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.